BEUDAMED
    FDA Enforcement Class I Terminated

    St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

    Recall: Z-0213-2018 · Reported January 3, 2018

    Enforcement

    Recall Number
    Z-0213-2018
    Event ID
    77470
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sterilmed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 3, 2018
    Initiation Date
    June 2, 2017
    Classification Date
    December 28, 2017
    Termination Date
    July 29, 2019
    Address
    5010 Cheshire Pkwy N Ste 2, N/A, Minneapolis, MN, 55446-4101, United States

    Description

    St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

    Reason

    Inadequate seal due to lack of adhesive glue

    Code Info

    Model No. STJ408309, STJ408310, STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots, known lots: 7344024, 7343120, 7343643, 7343797, 7348305, 7355750, 7348712, 7290257, 7354522, 7354523, 7350001, 7324499, 7343501, 7351203, 7255673, 7273483, 7343603, 7355439, 7355745, 7355754, 7355752, 7282741, 7315539, 7320863, 7343766, 7351038, 7330645, 7345143, 7323722, 7330603, 7342081, 7351724, 7352687, 7355130, 7355131, 7355137, 7377760, 7355135, 7375662, 7404300, 7404301, 7404316, 7404306, 7343395, 7355463, 7355714, 7355622, 7330666, 7355572, 7327999, 7355677, 7308337, 7343686, 7355680, 7251903, 7259400, 7322815, 7342069, 7355574, 7355676, 7355712, 7346336, 7355666, 7355661, 7355618, 7355571, 7354437, 7350573, 7331054, 7300290, 7350792, 7355679, 7355709, 7355713, 7355681, 7355675, 7355573, 7345129, 7343838, 7355678, 7355575, 7355620, 7355711, 7346820, 7355662, 7404299, 7404282, 7404294, 7404290, 7404310, 7404311, 7404318, 7404297, 7404287, 7342672, 7357129, 7241712, 7350942, 7272027, 7316930, 7345592, 7348169, 7388731, 7372138, 7386929, 7387147

    Distribution

    US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.

    Quantity

    112 devices